Evaluation of EMI in Patients With Micra Leadless Pacemaker

Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker

Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).

Study Overview

• Status: Completed
• Conditions: Electromagnetic Interference
• Intervention / Treatment: Other: surgical procedure

Detailed Description

Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.

Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60174
      • EdwardElmhurst Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with Micra leadless pacemakers implanted at Edward-Elmhurst Healthcare since May 2016 who then required a surgical procedure.

Description

Inclusion criteria:

• subjects with an implanted Micra pacemaker who required a surgical procedure

Exclusion Criteria:

• no Micra pacemaker

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Micra subjects; Surgical procedure	Other: surgical procedure; Surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EMI	Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms	up to 6 months next postop interrogation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device reset	Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms	up to 6 months next postop interrogation

Collaborators and Investigators

• Sponsor: Edward-Elmhurst Health System
• Investigators: Principal Investigator: Janet Gifford, MSN, Edward-Elmhurst Health

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): August 18, 2018
• Study Completion (Actual): August 18, 2018

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: EdwardH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes